Senior Regulatory Affairs Specialist at Boston Scientific

Department: Regulatory Affairs

Compensation

$89,200 – $169,500/yr

Setup: Hybrid
Location: Maple Grove, Minnesota
Type: Full-time
Level: senior
Posted: Jul 22, 2026

Description

Boston Scientific is hiring a Senior Regulatory Affairs Specialist to support regulatory affairs for product development, sustaining engineering, and acquisition integration in its Urology business. The role develops regulatory strategies, prepares global submissions including U.S. and EU MDR applications, reviews design and manufacturing changes, supports labeling and advertising compliance, and mentors cross-functional partners. It requires a bachelor's degree in a scientific or technical discipline and at least four years of regulatory affairs or related medical device experience, with implantable-device expertise. The position follows a hybrid model requiring at least three days per week in the local office and is based in Maple Grove, Minnesota, or Marlborough, Massachusetts. Visa sponsorship is not available, and the listed salary range is $89,200 to $169,500.

Required Skills

Regulatory strategy
Regulatory submissions
Design controls
Clinical trials
Technical writing
Microsoft Word

Additional Information

Minimum Education: Bachelor's degree in a scientific or technical discipline
Required Previous Experiences: At least 4 years of regulatory affairs or related medical device experience
Experience with implantable or active implantable medical device regulations
Experience supporting product development and sustaining activities for implantable or active implantable medical devices
Experience preparing regulatory submissions for medical devices
Experience working within product development and design controls
Preferred Qualifications: Experience preparing PMAs and 510(k)s for implantable or active implantable medical devices
Knowledge of clinical trial regulations
Cross-functional collaboration experience
Ability to manage multiple projects simultaneously
Research and analytical skills
Technical writing and communication skills
Ability to work independently with minimal supervision
Interpersonal and influencing skills
Proficiency with Microsoft Word, Excel, and PowerPoint